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Validation Manager - Ireland  

Company managed [?] Still accepting applications

Posted on : 25 April 2017

Project Description


About us:
  • Our company  is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. 
  • Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. 
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. 
  • Our company's  metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders,  to treat patients. 
  • In addition, our company  is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
 


 

Principal Responsibilities
  • Leading and Managing projects for the validation equipment, processes and products to meet all safety, quality, regulatory and operational requirements.
  • Review of equipment specification/design/procurement/installation and validation.
  • Project planning and execution including scheduling, task management, milestone planning and reporting.
  • Manage the process validation documentation process, through protocol generation, execution, and final approval. Ensure that all validation procedures are in alignment with current regulatory requirements.
  • Generation, review and approval of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
  • Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ etc),
  • To facilitate and participate in meetings and workshops as part of Continuous Improvement activities.
  • To approve plant SOPs and other documents as required, ensuring the acceptability of content and format.
  • Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency.
  • Accountable for compliance via documentation completion, risk assessments, review of protocols and reports, closing out preventative and corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Support and liaise with Technical Services in relation to the tech transfer of products into the facility.
  • Responsible for cleaning verification/validation and the execution of the cleaning verification and validation programs.
  • Responsible for the implementation and execution of the process validation program and continuous process verification.
  • Manage and perform data analysis and lead/support investigations as required and support the team to make informed decisions/recommendations around conclusions reached from data analysis, using appropriate methodologies as required.
  • Responsible for authoring portions of regulatory submissions and defending the commissioning, design and qualification of GMP equipment to regulatory agency representatives during inspections.
  • Work collaboratively to lead a safe and compliant culture in the company.
  • Develop and own Validation department budget.
  • Measure the Validation team's performance against Key Performance Indicators; creates plans to improve the quality and efficiency through continuous improvement.
  • Lead site preparation for regulatory audits with HPRA and FDA (and other) from a Validation perspective.
  • Monitors regulatory intelligence in validation expectations to ensure the site is always meeting the latest in regulatory expectations.
  • Process mapping and gap analysis to identify best practices and efficient methods of work within the validation group.
  • Ensure that all validation procedures are in alignment with current regulatory requirements.
  • May be required to perform other duties as assigned.

 

Qualifications
  • Minimum of 10 years employment in a cGMP biopharmaceutical or aseptic filling environment.
  • Must have direct experience performing equipment, utility, and/or computer system qualifications studies in a cGMP aseptic filling environment.
  • Experience of executing process validation of Drug Products
  • Must have direct experience of performing validation studies of thermal sterilization processes including Autoclave validation, Steam in Place (SIP) validation, and validation of depyrogenation processes.
  • Experience supervising personnel is required.
  • 5 years' experience in validation environment in a leadership role
  • Must have experience managing complex, multifunctional projects.
  • Experience in HPRA/FDA environment is required.
  • Strong technical writing and communication skills
  • Problem solving and Project Management skills essential.
  • Must be goal-oriented and able to prioritize and manage tasks

 

Education
  • Bachelor’s degree (Level 8) required; preference given to candidates with advanced degrees; 10 years or more of cGMP experience preferred; consideration will be given to other relevant experience and education.
  • Post-graduate studies as appropriate to augment primary degree would be desirable

 

About us:
  • Our company  is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. 
  • Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. 
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. 
  • Our company's  metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders,  to treat patients. 
  • In addition, our company  is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.